HISTEX PD DROPS NEW FORMULATION- triprolidine hydrochloride syrup

HISTEX PD Drops New Formulation by

Drug Labeling and Warnings

HISTEX PD Drops New Formulation by is a Otc medication manufactured, distributed, or labeled by Allegis Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 1 mL dropperful)

Triprolidine HCl 1.25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

Warnings

Do not exceed recommended dosage.

Ask a doctor before use if the child has

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma

Ask a doctor before use if the child is taking sedatives or tranquilizers

When using this product

• excitability may occur, especially in children
• may cause drowsiness
• sedatives and tranquilizers may increase the drowsiness effect

Stop use and ask a doctor if

• new symptoms occur

Keep out of the reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.

• use only the enclosed dropper.
• do not use enclosed dropper for any other drug products.

AGE	DOSE
Adutls & Children 12 years of age or older:	2 mL (2.5 mg) every 4 to 6 hours, not to exceed 8 mL (10 mg) in 24 hours or as directed by a doctor.
Children 6 to under12 years of age:	1 mL (1.25 mg) every 4 to 6 hours, not to exceed 4 mL (5 mg) in 24 hours or as directed by a doctor.
Children under 6 years of age:	Consult a docotor.

Other Information

Store at 15°-30° C (59°-86° F).

Tamper evident by foil seal under cap. Do not use if foil seal is missing or broken.

Inactive ingredients

bubble gum flavor, citric acid, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Questions? Comments?

Call 1-866-633-9033.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

NDC: 28595-809-30

HISTEX™ PD New Formulation

Drops

Antihistamine

Each dropperful (1 mL)

contains:

Triprolidine HCl

1.25 mg

Sugar-Free Dye Free

Alcohol Free

Bubble Gum Flavor

1 fl oz (30 mL) Bottle

INGREDIENTS AND APPEARANCE

HISTEX PD DROPS NEW FORMULATION 
triprolidine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28595-809
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM)	TRIPROLIDINE HYDROCHLORIDE	1.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28595-809-30	1 in 1 CARTON	12/13/2023
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	12/13/2023

Labeler - Allegis Pharmaceuticals, LLC (792272861)